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Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

SBRT (stereotactic body radiotherapy) may decrease or actually increase CTC levels in
patients with cancer, and knowledge about the effects of different therapies, including
SBRT, on CTC levels will be of general interest to the oncology community. Patients will
undergo blood draws at defined times as indicated below.

1. Prior to CT-simulation, but more than 2 days after digital rectal examination

2. Within 24 hours following CT simulation (an endorectal balloon is used at the time of

3. Within 24 hours following the first treatment

4. Within 24 hours following the third treatment

5. Within 1 week following the fifth treatment

Inclusion Criteria:

Men who satisfy all of the following conditions will be eligible for this study:

- Willing and capable to provide informed consent

- Signed study specific informed consent form.

- PSA ≤ 20 prior to hormone therapy (if given) for patients with Gleason 2-6. For
those with Gleason score of 7. PSA should be less than or equal to 15 ng/ml prior to
hormonal therapy (if given). Thus, risk of pelvic lymph node involvement according to
Roach formula would be under 20%.

- Gleason score ≤ 7

- Appropriate staging studies identifying as AJCC stage T1a, T1b, T1c, T2a, or T2b

- No direct evidence of regional or distant metastases after appropriate staging

- Histologic confirmation of cancer by biopsy

- Adenocarcinoma of the prostate

- Age ≥ 18

- Zubrod Performance Status 0-2

- Up to 9 months of previous hormonal therapy is allowed (but not required)

- AUA score must be ≤ 15 (alpha blockers allowed)

- CT or Ultrasound-based volume estimation of prostate gland ≤ 60 grams

- Agreement to use effective contraceptive methods such as condom/diaphragm and
spermicidal foam, intrauterine device, or prescription birth control pills.

Exclusion Criteria:

Women are not eligible for this study. Men with one or more of the following conditions
also are ineligible for this study:

- Positive lymph nodes or metastatic disease from prostate cancer

- Prior invasive malignancy unless disease free for a minimum of 3 years (carcinoma in
situ of the breast, oral cavity, or cervix, or non-melanomatous skin cancer are all

- T2c, T3, or T4 tumors

- Previous pelvic radiotherapy

- Previous surgery or chemotherapy for prostate cancer

- Previous transuretheral resection of the prostate (TURP) or cryotherapy to the

- Previous hormonal therapy given for more than 9 months prior to therapy

- Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally
fractionated radiotherapy, and chemotherapy) while on this protocol.

- History of Crohn's Disease or Ulcerative Colitis.

- Previous significant obstructive symptoms; AUA score must be ≤ 15 (alpha blockers

- Significant psychiatric illness

- Men of reproductive potential may not participate unless they agree to use an
effective contraceptive method.

- Ultrasound or CT estimate of prostate volume > 60 grams

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To review the level of changes in circulating tumor cells with radiation.

Outcome Description:

The investigator will review the coutns of circulating tumor cells (CTC). If there are significant changes in CTC levels with radiation, future studies will determine the prognostic significance of this information.

Outcome Time Frame:

2 weeks

Safety Issue:


Principal Investigator

Jeffrey Meyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center


United States: Institutional Review Board

Study ID:

STU 032011-212



Start Date:

July 2011

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • Low- and Intermediate-Risk Prostate Cancer
  • Neoplastic Cells, Circulating
  • Prostatic Neoplasms



University of Texas Southwestern Medical CenterDallas, Texas